Phase 2 N=35 Treatment

Stereotactic Radiosurgery and Radiation Therapy in Treating Patients With Glioblastoma Multiforme

Brain and Central Nervous System Tumors

Bottom Line

View on ClinicalTrials.gov: NCT00253448 ↗

Enrolled (actual)

Serious AEs

11.4%

Results posted

Jul 2011

Primary outcome: Primary: Overall Survival After Treatment — 15.8; 22; 18.7; 12.5 months

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: radiation therapy (Radiation); stereotactic radiosurgery (Radiation)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Case Comprehensive Cancer Center
Primary completion: Dec 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Overall Survival After Treatment	15.8; 22; 18.7; 12.5; 3.9; 20.8	—

Summary

RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving stereotactic radiosurgery together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving stereotactic radiosurgery together with radiation therapy works in treating patients with glioblastoma multiforme.

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed grade IV malignant glioblastoma multiforme
Diagnosis by surgical biopsy or resection within the past 5 weeks
Post-operative diagnostic contrast-enhanced MRI scan with MR spectroscopy must be performed prior to initiating study treatment
High-risk area of active tumor without margin by MR spectroscopy
Meets the following criteria for radiosurgery:
Maximum diameter ≤ 40 mm
Located > 5 mm from the optic nerve or chiasm
Does not involve the brainstem
No multifocal or recurrent malignant glioma

PATIENT CHARACTERISTICS:

Performance status

Karnofsky 50-100%

Life expectancy

At least 3 months

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

Other

Not pregnant
Negative pregnancy test

PRIOR CONCURRENT THERAPY:

Chemotherapy

At least 6 weeks since chemotherapy
Concurrent chemotherapy allowed

Endocrine therapy

Concurrent steroids allowed, but at the smallest therapeutic dose possible

Radiotherapy

No prior in-field radiotherapy to the head and neck

Surgery

See Disease Characteristics
Recovered from prior surgery or any post-operative complication

Other

Concurrent antiseizure medications allowed

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00253448). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.